Sterilization EUGMP- Annex-1
Questions 1. Terminal sterilization is preferred because:
A) It is faster than filtration
B) It provides greater sterility assurance
C) It requires no validation
D) It uses fewer resources
Answer: B
Questions 2. When terminal sterilisation is not possible, one alternative is:
A) UV sterilisation
B) Post-aseptic processing terminal heat treatment
C) Chemical fumigation only
D) No additional treatment
Answer: B
Questions 3. Sterilization cycle design should be based on:
A) Operator preference
B) Historical practices alone
C) Scientific principles and data
D) Cost-saving strategies
Answer: C
Questions 4. Critical sterilisation parameters must be:
A) Ignored during routine operation
B) Defined, controlled, monitored, recorded
C) Estimated only
D) Set by vendor only
Answer: B
Questions 5. All sterilisation processes must be:
A) Optional
B) Validated
C) Performed only once
D) Unmonitored
Answer: B
Questions 6. Validation studies must consider:
A) The operator’s training level
B) The colour of the product
C) Product composition and storage conditions
D) Packaging artwork
Answer: C
Questions 7. Validation must also consider:
A) Maximum time between preparation and sterilisation
B) Average room temperature
C) Time between inspection steps
D) Shipping duration
Answer: A
Questions 8. Validation must show that sterilisation achieves desired conditions in:
A) Only the largest items
B) Random parts of the load
C) All parts of each load
D) Only the equipment surfaces
Answer: C
Questions 9. Validation may include:
A) Financial risk assessment
B) Physical measurements and BIs
C) Colour testing
D) Odour measurement
Answer: B
Questions 10. Preferred sterilisation method where possible:
A) UV treatment
B) Heat sterilisation
C) Cold sterilisation
D) Gamma radiation
Answer: B
Barrier Technologies in Pharma
Questions 11. Extra attention is required when the sterilisation method:
A) Is inexpensive
B) Is described in pharmacopoeia
C) Is not described in pharmacopoeia
D) Uses steam
Answer: C
Questions 12. Loading patterns for sterilisation:
A) Need no validation
B) Should be validated and periodically revalidated
C) Should change daily without control
D) Cannot be standardized
Answer: B
Questions 13. Maximum and minimum loads:
A) May be ignored
B) Must be considered in load validation
C) Are irrelevant
D) Should never be used
Answer: B
Questions 14. Sterilization process validity should be:
A) Reviewed based on risk
B) Reviewed only during audits
C) Ignored once validated
D) Reviewed every 10 years
Answer: A
Questions 15. Worst-case heat sterilisation cycles should be revalidated:
A) Monthly
B) Every 5 years
C) At least annually
D) Never
Answer: C
Questions 16. Routine operating parameters must be:
A) Ignored
B) Established and adhered to
C) Left for operators to choose
D) Based on vendor defaults
Answer: B
Questions 17. Mechanisms must exist to detect:
A) Operator sleeping
B) Cart movement
C) Sterilization cycles outside validated parameters
D) Temperature fluctuations in the warehouse
Answer: C
Questions 18. Any sterilisation cycle deviation:
A) Should be ignored if small
B) Must be investigated
C) Should be repeated without review
D) Should be recorded but not reviewed
Answer: B
Questions 19. Biological indicators (BIs) may be used to:
A) Replace all physical monitoring
B) Support validation of sterilisation
C) Eliminate need for calibration
D) Replace heat indicators
Answer: B
Questions 20. BI positive controls must be tested:
A) Annually
B) Every 10 cycles
C) For each sterilisation cycle (where applicable)
D) Never
Answer: C
Questions 21. BI results:
A) Can override critical parameters
B) Should be used alone for batch release
C) Should not override critical parameters
D) Replace the need for validation
Answer: C
Questions 22. BI suppliers must be:
A) Unqualified
B) Qualified
C) Rotated monthly
D) Located locally
Answer: B
Questions 23. BI transport and storage conditions:
A) Are unimportant
B) Should be tightly controlled
C) Should be decided by operators
D) Must be unknown
Answer: B
Questions 24. Before using new BI lots, one must verify:
A) Packaging colour
B) Population, purity, identity
C) Cost and delivery time
D) Shape of the container
Answer: B
Questions 25. Differentiation between sterilised and non-sterilised items should be:
A) Arbitrary
B) Clear and controlled
C) Optional
D) Avoided to save time
Answer: B
Questions 26. Baskets or trays should be labelled with:
A) Operator name
B) Machine type
C) Product name, batch number, sterilisation status
D) Only sterilisation status
Answer: C
Questions 27. Autoclave tape or irradiation indicators show:
A) Sterility of items
B) That sterility assurance level was achieved
C) Only that a process occurred
D) Bioburden levels
Answer: C
Questions 28. Sterilization records must exist for:
A) Every sterilisation run
B) Only critical sterilisation runs
C) Only weekly runs
D) None
Answer: A
Questions 29. Each sterilisation cycle should have:
A) A colour code
B) No identification
C) A unique identifier
D) A handwritten label
Answer: C
Questions 30. Sterilization record review is part of:
A) Warehouse activities
B) Batch certification/release
C) Process deviation reporting only
D) HR training
Answer: B
Questions 31. Sterilized items not used immediately must be:
A) Discarded
B) Stored with appropriate sealed packaging
C) Exposed to air
D) Washed again
Answer: B
Questions 32. Maximum hold time for sterilized items must be:
A) Unlimited
B) Not defined
C) Established
D) Arbitrary
Answer: C
Questions 33. Multiple sterile packaging layers may allow storage:
A) Outside cleanrooms, if justified
B) Only in Grade A
C) Only in Grade B
D) Without packaging
Answer: A
Questions 34. Packaging processes providing protection must be:
A) Performed after sterilisation
B) Performed prior to sterilisation
C) Ignored
D) Performed only by contractors
Answer: B
Questions 35. Transfer of sterilized packaged items into Grade A requires:
A) No disinfection
B) Validated methods (e.g., airlocks, pass-throughs)
C) Manual carrying
D) Use of forklifts
Answer: B
Questions 36. Exterior disinfection of sealed packaging must be:
A) Avoided
B) Performed and demonstrated effective
C) Performed only when visibly soiled
D) Optional
Answer: B
Questions 37. Packaging used for sterilised items must be qualified to minimise risk of:
A) Ink fading
B) Particulate, microbial, endotoxin/pyrogen contamination
C) Colour mismatch
D) Noise
Answer: B
Questions 38. Packaging sealing processes must be:
A) Uncontrolled
B) Validated
C) Performed only manually
D) Ignored
Answer: B
Questions 39. Items that cannot be sterilised must undergo:
A) No treatment
B) Disinfection and validated transfer process
C) Storage at room temperature
D) Visual inspection only
Answer: B
Questions 40. Disinfected items that cannot be sterilised must be:
A) Exposed to air
B) Left unprotected
C) Protected from recontamination
D) Stored in Grade A
Answer: C